510(k) Report

510(k) · Cleared

Cleared

Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute

K950956510(k) TraditionalCleared Jun 2, 199592-day reviewClass II21 CFR 882.5910

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Bio-Vascular, Inc. · GXQ Dura Substitute

Cleared on Jun 2, 1995 after a 92-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 43 later devices descend from it.

Decided
Jun 2, 1995
Review
92 days
Class
Class II
Product code
GXQ
Recalls
None
Predicates
0

43 later devices descend from it, 6 citing it directly.

Descendants, by year cleared 1997: 1 descendant cleared2014: 1 descendant cleared2012: 2 descendants cleared2003: 2 descendants cleared2004: 4 descendants cleared2000: 1 descendant cleared2016: 4 descendants cleared2013: 3 descendants cleared2017: 3 descendants cleared2006: 2 descendants cleared2022: 1 descendant cleared1999: 1 descendant cleared1998: 1 descendant cleared2019: 1 descendant cleared2015: 3 descendants cleared2002: 1 descendant cleared2007: 2 descendants cleared2010: 1 descendant cleared2005: 2 descendants cleared2023: 2 descendants cleared2025: 2 descendants cleared2026: 2 descendants cleared2020: 1 descendant cleared1995200020052010201520202025
  1. This deviceK950956 Dura-Guard Dural Repair Patch, Dura-Guard Dura SubstituteBio-Vascular, Inc. · 1995
  2. Descendant · cites it directly · 33 of its ownK973706 Dura-Guard-Dural Repair PatchBio-Vascular, Inc. · 1997
  3. Descendant · 2 generations on · 30 of its ownK982180 Duragen Dural Graft MatrixIntegra Lifesciences Corp. · 1999 · Recalled
  4. Descendant · cites it directly · 14 of its ownK991413 Codman Ethisorb Dura PatchJohnson & Johnson Professionals, Inc. · 2000
  5. Descendant · 2 generations on · 13 of its ownK982282 Dura-Guard - Dural Repair PatchBio-Vascular, Inc. · 1998 · Recalled
  6. Descendant · 3 generations on · 9 of its ownK032693 Duragen Plus Dural Graft MatrixIntegra Lifesciences Corp. · 2003 · Recalled

Showing 5 of 43 descendants. See all descendants

Descendants cleared per year

1997: 11998: 11999: 12000: 12002: 12003: 22004: 42005: 22006: 22007: 22010: 12012: 22013: 32014: 12015: 32016: 42017: 32019: 12020: 12022: 12023: 22025: 22026: 2
1997high 4 (2004) · low 0 (2001)2026

Most influential descendants

Showing 5 of 43 · See all
  • K973706Dura-Guard-Dural Repair PatchBio-Vascular, Inc. · 1997 · cites it directly33descendants
  • K982180Duragen Dural Graft MatrixIntegra Lifesciences Corp. · 1999 · 2 generations on30descendants
  • K991413Codman Ethisorb Dura PatchJohnson & Johnson Professionals, Inc. · 2000 · cites it directly14descendants
  • K982282Dura-Guard - Dural Repair PatchBio-Vascular, Inc. · 1998 · 2 generations on13descendants
  • K032693Duragen Plus Dural Graft MatrixIntegra Lifesciences Corp. · 2003 · 3 generations on9descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K950956Dura-Guard Dural Repair Patch, Dura-Guard Dura SubstituteBio-Vascular, Inc.1995—
+1K973706Dura-Guard-Dural Repair PatchBio-Vascular, Inc.1997—
+2K982180Duragen Dural Graft MatrixIntegra Lifesciences Corp.19991
+1K991413Codman Ethisorb Dura PatchJohnson & Johnson Professionals, Inc.2000—
+2K982282Dura-Guard - Dural Repair PatchBio-Vascular, Inc.19981
+3K032693Duragen Plus Dural Graft MatrixIntegra Lifesciences Corp.20031

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199710
199810
199910
200010
200210
200320
200440
200520
200620
200720
201010
201220
201330
201410
201530
201640
201730
201910
202010
202210
202320
202520
202620
FIG. 1 — Lineage of K950956, 1995–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in GXQ? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new GXQ device

  1. #1 K251191 Collagen Dura Regeneration Membrane - Repairscore 12.2 · 7 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA has not posted a summary or statement for it, so its predicates are not known.

What descends from it? (43)

See all 43

6 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K973706Dura-Guard-Dural Repair PatchBio-Vascular, Inc.199733
K991413Codman Ethisorb Dura PatchJohnson & Johnson Professionals, Inc.200014
K040888Duramatrix Collagen Dura Substitute MembraneCollagen Matrix, Inc.20043
K113071Synthecel Dura Replacement DevicesSynthes20122
K031850Durasis Dural SubstituteCook Biotech, Inc.20032
K132850Bovine Pericardium Suturable Dural Graft, Tutopatch DM Graft, Tutoplast Bovine…Rti Surgical, Inc.20140

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K973706 (Bio-Vascular, Inc., 1997) has gone furthest, with 33 descendants of its own.

How does its category compare?

All GXQ devices

GXQ Dura Substitute: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · GXQ

2in 2025

2007: 22010: 12012: 22013: 32014: 12015: 32016: 32017: 22019: 12022: 12023: 12025: 2
2007high 3 (2013) · low 0 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · GXQ

94in 2016

2013: 181 days median2015: 214 days median2016: 94 days median
2007high 214 (2015) · low 94 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · GXQ

2in 2024

2010: 62013: 12021: 22024: 2
2007high 6 (2010) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · GXQ

61in 2025

2007: 552008: 432009: 462010: 362011: 312012: 382013: 722014: 182015: 622016: 582017: 572018: 942019: 632020: 1142021: 762022: 592023: 1092024: 552025: 61
2007high 114 (2020) · low 18 (2014)2025

MAUDE reports naming product code GXQ, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20072—055
20080—043
20090—046
20101—636
20110—031
20122—038
20133181172
20141—018
20153214062
2016394058
20172—057
20180—094
20191—063
20200—0114
20210—276
20221—059
20231—0109
20240—255
20252—061
20260—0—

More from Bio-Vascular, Inc.

26 FDA decisions under this applicant name. See the company

  • K002233Bvi SlingBio-Vascular, Inc. · 20001 recall
  • K992537Peri-Strips-Sleeve, Peri-Strips-Strip and Peri-Strips Dry (Non-Naoh-Treated and Naoh-TreatedBio-Vascular, Inc. · 2000
  • K983602CV Peri-Guard and Vascu-GuardBio-Vascular, Inc. · 19983 recalls
  • K983581Ocu-Guard and Ocu-Guard SuppleBio-Vascular, Inc. · 1998
  • K983162Peri-Guard, CV Peri-Guard, Ocu-Guard, Supple Peri-Guard, Peri-Strips - Sleeve, Peri-Strips-Strips…Bio-Vascular, Inc. · 19982 recalls

Recent decisions in GXQ

The GXQ category page

  • K251191Collagen Dura Regeneration Membrane - RepairCollagen Matrix, Inc. · 2025
  • K250420Helios Dura Regeneration MatrixHelios Biomedical, Inc. · 2025
  • K223445ArtiFasciaNurami Medical, Ltd. · 2023
  • K212943SyntheCel Dura RepairSynthes (USA) Products, LLC · 2022
  • K183513XenoSure Dura Biologic PatchLeMaitre Vascular, Inc. · 2019

https://510kreport.com/device/K950956 · printed Nov 4, 2026

Cite this page

510(k) Report. “K950956: Dura-Guard Dural Repair Patch, Dura-Guard Dura Substitute.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K950956

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026